Randomized, multicentre phase II trial of the sequencing of Radium-223 and Docetaxel plus prednisone in symptomatic bone-only metastatic castration-resistant prostate cancer (mCRPC)
- Conditions
- symptomatic bone-only metastatic castration-resistant prostate cancerMedDRA version: 20.0Level: LLTClassification code 10001186Term: Adenocarcinoma of prostateSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-004452-29-IT
- Lead Sponsor
- ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 70
1. Patients must have histologically or cytologically confirmed adenocarcinoma of prostate
2. Two or more bone metastases confirmed by bone scintigraphy within 4 weeks prior to study entry
3. Known castration-resistant disease, defined according to PCWG3 criteria as: castrate serum testosterone level: =50 ng/dL (=1.73 nmol/L)
4. Subjects who have failed initial hormonal therapy, either by orchiectomy or by using a GnRH agonist in combination with an anti-androgen, must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks
5. Progressive disease based on PSA and/or radiographic criteria
6. ECOG performance status =2
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
1. Patients who have had previous chemotherapy.
2. Patients who have had radiotherapy within 4 weeks prior to entering the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the effects of sequential treatment between radium-223 and docetaxel on the percentage of symptomatic bone-only CRPC patients experiencing improvement or worsening in health-related quality of life (HRQoL).;Secondary Objective: To compare survival in patients treated with sequential therapy between radium-223 and docetaxel and to identify predictive factors of Radium-223 for clinical outcome in this patient population.;Primary end point(s): QoL clinical benefit;Timepoint(s) of evaluation of this end point: 36 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1) Progression-free survival (PFS)<br>2) Total progression-free survival (TPFS)<br>3) Overall survival (OS)<br>4) Safety <br>5) Identification of markers predictive to clinical outcome ;Timepoint(s) of evaluation of this end point: 1) 36 months<br>2) 36 months<br>3) 36 months<br>4) 36 months<br>5) 36 months